NCT03818282

Brief Summary

Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_2 ovarian-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

4.3 years

First QC Date

January 24, 2019

Last Update Submit

February 25, 2019

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free Survival

    PFS

    2 year

Study Arms (1)

Paclitaxel for injection (albumin-bound)

EXPERIMENTAL
Drug: Paclitaxel for injection (albumin-bound)

Interventions

Paclitaxel for injection (albumin-bound)DRUG

Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.

Paclitaxel for injection (albumin-bound)

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 75 years;
  • Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer;
  • Patients with stage IC-IV according to the International Federation of Obstetrics and Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment;
  • Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable according to GCIG criteria;
  • ECOG performance status of 0-2;
  • Expected survival ≥ 3 months;
  • Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90 g/L;
  • Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤ 5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN in patients with Gilbert's syndrome;
  • Must agree to use effective contraception during the trial; Women of childbearing potential must have a negative serum or urine pregnancy test; Non-lactating patients.

You may not qualify if:

  • Ovarian low-grade malignant tumor patients;
  • Patients who have received abdominal or pelvic radiotherapy;
  • Patients with central nervous system disease or brain metastases;
  • Other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured;
  • Prior Grade ≥ 2 sensory or motor neuropathy;
  • Uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
  • Known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients;
  • Receive other study drug chemotherapy within 30 days of the first dose of chemotherapy;
  • Patients not suitable for participation in this study judged by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

PaclitaxelInjections

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDrug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Ding Ma, M.D.

CONTACT

02783663351dma@tjh.tjmu.edu.cn

Danhui Weng, M.D.

CONTACT

02783663351weng.dh@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 24, 2019

First Posted

January 28, 2019

Study Start

March 1, 2019

Primary Completion

June 30, 2023

Study Completion

December 31, 2024

Last Updated

February 26, 2019

Record last verified: 2019-02